- Create revise and approve BioMarin Phase Appropriate Quality Systems documentation
- Represent Clinical Quality Department in cross functions forums.
- Draft and approval of Quality Technical Agreements with CDMOs as required for internal support
- Provide quality oversight for internally manufactured early-stage products and starting materials
- Provide support to audits and inspections of CDMOs and internal manufacturing and testing organizations
- Provide quality oversight of one or more portions of operations including, but not limited to:
- Release clinical phase 1 and 2 materials ensuring compliance with phase appropriate lot release requirements.
- Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities.
- QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations
- Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs.
- Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
- Perform QA Walkthroughs for 300 BMK manufacturing product changeovers
- Review and approval of SOP revisions initiated by manufacturing, Facilities and Engineering and Analytical support for 300 BMK Operations
- Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments.
- Ensure manufacturing and adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).
- 7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions.
- Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required.
- Computer literacy required, including Microsoft PowerPoint, Word, Excel.
- Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues.
- Results oriented; effectively manages a multitude of projects efficiently.
- Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported.
- Experience managing internal and external project stakeholders.
- Excellent written and verbal skills; ability to communicate effectively with all levels of the organization.
- Builds relationships with other functions, shares best practices, and solves shared problems.
- Demonstrates in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally.
- Demonstrates substantial knowledge of industry best practices and trends.
- Positive, solution focused outlook on daily challenges.
- BA/BS from an accredited University/College
- 7+ years of experience with biotechnology, pharmaceuticals or human healthcare industries.
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Technical Manager, Clinical QA - Novato, United States - BioMarin Pharmaceutical
Description
Who We Are
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
